High-dose Hydroxocobalamin (Vitamin B12a) for Vasopressor Refractory Hypotension Following Cardiopulmonary Bypass
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-011130
NCT ID: NCT03735316
Sponsor Protocol Number: 17-011130
About this study
The purpose of this study is to demonstrate an improvement in arterial blood pressure and a decrease in vasopressor requirement with administration of B12a in patients with post-cardiotomy vasoplegic syndrome on high-dose vasopressors.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Any patient for whom we are able to obtain consent prior to their procedure or after their procedure in the intensive care unit.
- Patient must have a PA catheter, or a CCO/Flo Trak for the procedure.
- Is presenting for a procedure in which CPB will be required.
- Is considered high risk for VS.
- Patient considered to be at high risk for the development of VS will be identified per the guidelines developed by Levin et al. This includes any patient:
- With pre-CPB vasopressor requirement(s); or
- On pre-operative ACE, or beta-blocker or calcium channel blocker therapy; or
- With a euroSCORE > 6; or
- Presenting for pericardiectomy, aneurysm surgery, LVAD surgery or heart transplant, CABG or valve surgery other than a single mitral valve repair.
- Has no contraindications to arterial line or PA catheter placement
- Patient must fall into the defined parameters below for the majority of measurements over a 30 minute period (ex: 3 out of 5 measurements or 6 of 10, etc.):
- Develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with VS within 24 hours of coming off CPB;
- “High-dose vasopressor” will be defined as:
- Norepinephrine infusion ≥ 0.1 mcg/kg/min; and/or
- Dopamine infusion ≥ 15mcg/kg/min; and/or
- Epinephrine infusion ≥ 0.1mcg/kg/min; or
- Norepinephrine equivalent infusion of ≥ 0.1mcg/kg/min.
- “Hypotension consistent with VS” will be defined as:
- MAP< 75 mmHg via arterial line monitor.
- Cardiac index > 2.3L/min/m^2 via PA catheter monitor.
- If at the time study drug arrives, the patient who previously met criteria has fallen out, they must once again meet requirements only one time before the drug is given.
Exclusion Criteria:
- Age < 18 years old.
- Known pregnancy or patients without a documented pregnancy test if not menopausal.
- Known prior anaphylactic or allergic reaction to B12a.
- CKD stage 4 or worse (GFR < 30 ml/min) before study drug administration.
- ECMO (extracorporeal membrane oxygenation) or IABP (intra-aortic balloon pump)prior to study consent and post cardiopulmonary bypass.
- Patients currently on cardiopulmonary bypass.
- Circumstance for which the safety of the patient could be jeopardized by continued adherence to the study protocol.
Eligibility last updated 1/11/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator James Nelson, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available